This invention relates to the field of cellular immune reactions; and, more particularly, to a method and apparatus for the direct and/or indirect determination of the degree of reaction (if any) between a foreign entity and a subject's white blood cells, for diagnosing a malady of the subject.
Diagnosing maladies is perhaps the single most important aspect of medicine. The key to diagnosing a malady is based on an understanding of the malady's cause.
Many illnesses and afflictions (i.e. maladies other than illnesses, such as an allergy or cancer) are caused by an individual's coming into contact with foreign entities, such as environmental chemicals, including known or possible carcinogens, other toxins or micro-organisms, including viruses and bacteria.
Every day, the human body is exposed to many types of foreign entities, and when so exposed, the body may ingest some foreign entities, by eating or breathing them in, or perhaps merely by touch. Once a foreign entity is ingested, the body identifies it either as being neutral, in which case the body does not react in any extraordinary fashion, or identifies it as being potentially harmful, in which case the body acts to defend itself.
If the foreign entity is in fact harmful, such as a carcinogen or a virus, it will cause certain ill effects to the individual, such as disease. However, even if the foreign entity is benign, and might not cause any untoward effects by itself, the reaction of the body to its identification as being harmful may have its own set of ill effects, such as an allergic reaction.
The body's defenses, primarily the immune system, and the manner in which they act to defend the body, have been greatly studied. In broad terms, the white blood cells (leukocytes) in an individual's blood act as the first line of defense against foreign entities classified as harmful. Once a foreign entity is identified as being harmful, besides the natural (innate) immune response, the body may produce specific antibodies which combine with the foreign entity and, in conjunction with the leukocytes, destroy the invading foreign entity.
I have observed three different steps in the response of the leukocytes to a foreign entity identified as harmful, after the antibodies and leukocytes combine.
First, the leukocyte increases in volume, to surround and enclose the foreign entity. This reaction is similar or identical to a phagocytosis reaction, in which a cell ingests a particle, Bellanti, J. A., Immunology III, W. B. Saunders Co. (1985), p. 16.
Second, after the foreign entity is enclosed by the leukocyte, the volume of the leukocyte decreases in a so-called complement reaction, i.e. the leukocyte develops a small defect in its cell membrane, and begins to extrude a portion of its cellular material, Bryant, N. J., Immunohematology, W. B. Saunders Co. (1982), pp. 54-55.
Finally, the leukocyte releases all of its cellular material, and breaks up its outer membranes. This reaction is similar to the degranulation of basophiles noticed in the presence of IgE mediated reactions, Bellanti, supra., p. 252.
Many theories exist as to the precise mechanism behind the operation of the immune system, i.e. how leukocytes recognize and define harmful foreign entities, and how antibodies are produced, etc. No currently known theory, however, explains all aspects of the body's defensive reactions. In addition, no currently known theory is generally accepted as the sole basis for explaining the reactions.
This lack of an understanding of the immune system response has hampered efforts to devise a uniform and comprehensive diagnostic tool or method for the diagnosis of a wide spectrum of maladies. Since a comprehensive understanding of the mechanics of the immune response is lacking, there is no comprehensive understanding of how maladies may be recognized at an early stage.
Currently, diagnosis of a malady is more or less by a look-up method. A subject approaches a doctor and relates his symptoms. The doctor then matches those symptoms with the symptoms of known maladies, and attempts to cull a short list of possible causes from all of the conceivable causes. Based on this list, the doctor will perform tests to isolate the cause of the malady. If there is no positive test result, then a new series of tests will be performed, and this procedure continues until a positive result is attained. This may take a great deal of time and expense, and some of the tests performed may be discomforting or even painful for the subject.
This procedure is necessary because most tests are directed to specific symptoms of an illness. For example, an illness which affects kidney function may be indicated by an increased level of urea in the subject's bodily fluids. The test, then, for that kidney ailment, would be to check the level of urea in the subject's bodily fluids. Such tests do not identify the malady per se, but rather measure an expected bodily response to the malady's presence.
The look-up method has many drawbacks, however. First, it depends upon the subject's ability to recognize symptoms. If the subject has not started to feel the effects of the malady, then he may not know enough to tell the doctor of a minor symptom which would indicate a serious malady. It is for this reason that a wide battery of tests is often prescribed for a new subject, to ascertain to the extent possible what may be ailing that subject.
These tests may be time-consuming, expensive and even painful. Additionally, if the right tests are not called for, someone may be diagnosed as being in good health, but in fact have a massive tumor (for example) which has not yet begun to cause any visible symptoms. If a subject is suffering from more than one malady, the various symptoms may also mask or disguise each other, leading to a false diagnosis.
A different problem arises if two maladies have similar symptoms. A diagnosis based on symptoms may be unable to discern two completely different maladies having similar symptoms.
Furthermore, the subjectivity of an individual as to the experiencing or relating of certain symptoms may also come into play. For example, a slight headache may not cause an individual any great concern, but may in fact indicate a brain tumor.
An incorrect and possibly fatal diagnosis is always a serious concern to doctors, and there is a serious need for an objective test which may be used to diagnose a variety of maladies, without the possibility of masking or disguising of symptoms, and which may be performed effectively, relatively inexpensively, objectively, and quickly.
Further complicating this situation is the possibility that a particular malady may not cause any noticeable symptoms until it has become quite serious. Thus, the afflicted individual may not know enough to have tests performed.
The test described in my above-referenced Patent assists in the diagnosis of allergies by a simple blood test. That Patent, however, does not disclose any applicability of the test disclosed therein beyond allergies.
Furthermore, prior tests are not useful in diagnosing maladies for which there are no antibodies produced by the subject. If the introduction of the foreign entity to the body does not result in the production of antibodies specific to the foreign entity, then the body will not react to attack it and no reaction will take place. This is the case, for example, with respect to carcinogens. Since the body may not produce any natural antibodies specific to the carcinogen, the body may not act to attack it. Thus, a cancer caused by the carcinogen is free to develop unfettered, until it is of a size sufficient to be detected by other conventional means, such as by palpation or X-ray. No early detection is possible, however, until symptoms are evident. In many instances, the onset of symptoms means imminent death.
There is thus a need for an objective test which may be used to diagnose a wider variety of maladies, and which may be used to diagnose maladies caused by the ingestion of foreign entities for which no antibodies are produced by the subject. There is also a need for a method of diagnosis in which maladies may be diagnosed at a stage before the onset of externally observable symptoms.